FDA.reportPublic FDA data

DRAEGER MEDICAL SYSTEMS, INC.

Matched from indexed company URL: Draeger, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25109542510954DRAEGER MEDICAL SYSTEMS, INC.1N2026-01-013135 QUARRY RD. Telford PA US 18969
25179672517967DRAEGER, INC.1Y2026-01-013135 QUARRY RD. TELFORD PA US 18969
30011040933023530182DRAEGERWERK AG & CO. KGAA1N2026-01-01REVALSTRASSE 1 LUEBECK Schleswig-Holstein DE 23560
30057834253005783425DRAEGER MEDICAL SYSTEMS, INC.1N2026-01-016 TECH DRIVE ANDOVER MA US 01810
30093484233009348423DRAEGER, INC.1N2026-01-017256 S. Sam Houston W. Parkway Suite 100 Houston TX US 77085

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs. - MU10841+18004372437info@draeger.com
04049098053785Infinity etCO2 SmartPod - 5740720+18004372437info@draeger.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1941012048865808K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4CBK1999-08-24
647261451217962K991884SIEMENS FIO2 SENSORCCL1999-11-03
647261006235521K991012SIEMENS INFINITY EEG PODOLT1999-06-24
1941011860720296K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900CBK1998-12-07
1941011686536133K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419BTI1998-10-29
1941011898199291K980642EVITA 4 (8411900)CBK1998-09-04
647261826177765K980287SIEMENS SC9000/SC9015 TCP02/C02 MODULEKLK1998-08-12
1941011605850046K974176BABYLOG 8000 PLUSCBK1998-06-17
1941011213047768K971198BABYTHERM 8004 BABYTHERM 8010FMT1997-10-03
1941011757044554K970165EVITA 2 DURACBK1997-08-26
1941011050940240K961687EVITA 4CBK1996-12-13
647251107555391K960980ISOLETTE INFANT INCUBATORFMZ1996-07-30
647261763549429K954632SIEMENS SC 9000 ETCO2 MODULECCK1996-02-05
1941011664838576K954611DRAGER PT4000 PHOTOTHERAPY SYSTEMLBI1995-12-01
1941011131590702K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORSCBK1996-11-05
647251037976987K941106MODEL TI500 ISOLETTE INFANT INCUBATORFPL1994-06-10
647251233275704K940975C450/C400 INFANT INCUBATORSFMZ1994-06-23
647251808397874K940951RW RESUCITAIRE INFANT RADIANT WARMERFMT1995-05-03
1941011574159165K926292BABYLOG 8000 INFANT VENTILATORCBK1994-04-19
647251501421038K912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEMLBI1991-12-13
1941011032185778K903089BABYLOG 8000 INFANT VENTILATORCBK1991-06-10
647251059304309K875270INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUSFMT1988-01-19
647251197879778K872742WARM WEIGH MODELS I-20/W-30 INFANT SCALEFMT1987-10-20
647251202140592K840454PHOTOTHERAPY UNIT 7850 NEONATAL PHOTOLBI1984-03-23
647252030736439K810953MODEL 533 PHOTOTHERAPY UNITLBI1981-04-23
647251176195398K810474PROBE COVERFLL1981-03-31
1941011320805815K253647Evita (V800); Evita (V600)CBK2026-05-07
1941011676623042K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ2026-05-21
1941011752251792K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterDSA2025-09-30
1941011540570274K251619Babyleo TN500FMZ2026-02-13
647251997021696K243606Babyroo TN300FMT2025-01-17
647261194330787K240312Infinity CentralStation WideMHX2024-08-01
647261968438326K233834Infinity Gateway SuiteMSX2024-07-12
647261503551261K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX2023-10-17
1941011324499592K230931AtlanBSZ2023-07-23
647251411449550K230278Babyroo TN300FMT2023-05-30
1941011163229020K222207Babylog VN800, Babylog VN600CBK2023-05-16
1941011999518526K222024Evita V800, Evita V600CBK2023-05-16
1941011407891573K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH2022-12-07
1941011695196534K221118CO2 Mainstream SensorCCK2023-04-05
647261192638153K203579Infinity Gateway SuiteMSX2022-06-07
647261126312858K203088Infinity Acute Care System (IACS) Monitoring SystemMHX2022-02-01
647261543244484K200859Infinity M300MHX2020-08-28
647251031803981K182977Isolette 8000 PlusFMZ2018-11-21
1941011597278230K182859Babyleo TN500FMZ2019-02-22
1941011608452075K180779Savina 300CBK2019-01-17
647251050683443K172656BiliLuxLBI2018-05-01
647251778672988K172154Isolette 8000 plusFMZ2018-04-19
1941011760528713K162821Babyleo TN500FMZ2017-06-23
647261175483872K152407Infinity Delta, Infinity Delta XL, Infinity KappaMHX2015-09-23
647261258207932K151860Infinity CentralStation WideMHX2015-09-02
647261645019414K141756INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATIONMSX2014-12-12
647251057763122K141565GLOBE-TROTTER GT5400FPL2014-09-10
1941011630692707K133886PERSEUS A500BSZ2014-06-20
647251206732922K133175DRAEGER JAUNDICE METER JM-105MQM2014-11-13
647261015635870K130711INFINITY CENTRALSTATION WITH INFINITY M300MHX2013-04-11
1941011612598380K123776POLARIS 100/200FTD2013-03-08
1941011195384654K121886SAVINA 300 SAVINA 300, COUNTRY VARIANTSCBK2014-08-08
647251834461399K120642RESUSCITAIRE WITH AUTOBREATHFMT2012-11-02
647261041296909K113798INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETMHX2012-03-22
647251308972471K113206NANOBLUTM 500LBI2012-02-17
1941011710742081K103625OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICECBK2011-10-06
647261694293972K102968INFINITY CNAP SMARTPODDXN2011-02-18
647261390991427K093788INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTIONMHX2010-03-08
1941011706651892K093633INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARECBK2010-03-30
1941011916571946K093632INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARECBK2010-04-05
1941011935193492K083050EVITE XLCBK2008-12-29
647261352376586K082888INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997DQA2008-11-26
1941011561628354K082600OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)CBK2008-11-26
1941011150903776K081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKSCBK2008-09-22
647262046646983K073113INFINITY PICCO POD, MODEL MS16734DXG2008-01-03
1941011859578665K072885CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110CBK2008-04-07
1941011742254646K072884FABIUS MRIBSZ2008-07-30
647261804862730K070566INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XLMHX2007-06-04
1941011450301912K062267OXYLOG 3000CBK2006-10-31
647261950566620K061379INFINITY TELESMART TELEMETRY SYSTEMMHX2007-02-16
647261867863385K061329INFINITY MASIMO SET SP02 PODDQA2006-07-07
1941011603961499K060254MODIFICATION TO INFINITY EXPLORERMSX2006-04-04
647261269831947K060223INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEMMHX2006-04-12
647261353198615K053484INFINITY GAMMA / GAMMAXL, INFINITY VISTAMHX2006-02-22
647252015844469K053399VERSALET 7700 CARE CENTERFMZ2006-08-04
1941011276825448K051628INFINITY MONITORS WITH SCIO MODIFICATIONSMHX2005-07-20
1941011251301918K051263EVITAXL WITH OPTION SMARTCARECBK2005-07-12
647261207168481K050974DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSDRQ2005-04-29
647261663998606K043549INFINITY GATEWAY SUITE, VF4MHX2005-01-21
647261875582276K042904INFINITY KAPPA XLTMHX2005-02-18
1941011376844085K042607PRIMUS USBSZ2004-11-26
647252016554863K042522JAUNDICE METER, MODEL JM 103MQM2005-07-06
1941011580132859K042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-10-08
1941011842116697K042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-08-31
647261883928552K042003INFINITY TRIDENT NMT PODKOI2004-09-01
1941011578302047K041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMBSZ2004-07-08
1941011872089325K040642LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINACBK2004-06-02
647261201849746K040188INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULENHP2004-04-14
647251449951920K033498NARKOMED 6400, MODEL NM6400BSZ2004-04-26
1941011021795746K031400FABIUS TIRO ANESTHESIA SYSTEMBSZ2003-07-15
647251518332844K031387ISOLETTE INFANT INCUBATOR, MODEL C2000EFMZ2003-08-01
1941011741084665K030624MODIFICATION TO FABIUS GS ANESTHESIA SYSTEMBSZ2004-03-17
1941011125345455K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072CBK2003-01-15
1941011841838953K012177VENTVIEW, MODEL 8414095CBK2001-09-04
1941011285878813K011404FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GSBSZ2002-02-22
1941011750216517K010793OXYLOG 1000, MODEL 2M86840CBK2001-12-20
1941011898758805K010724SOLA 700,SOLA 500, SOLA 300FTD2001-06-07
1941011736648351K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474CBK2001-06-14
647261835344576K003550INFINITY ETCO2 + RESPIRATORY MECHANICS PODCCK2001-03-07
647251552437597K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMERFMT2000-11-17
1941012059795240K003068SAVINACBK2001-06-25
1941011455337928K003067CALEOFMZ2000-12-13
647251661068163K001242ISOLETTE INFANT INCUBATOR, MODEL C2HSFMZ2000-07-13
647251634143623K001019TI500 GLOBE-TROTTER TRANSPORT SYSTEMFPL2000-04-27
1941011331807071
647261134999538
647261335413908
1972801383287588
1941011512244650
647261606188385
1941011635605479
1941011835950066
647261915329208
647261940572811

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBK292026-05-07
MHX162024-08-01
BSZ122026-05-21
FMZ112026-02-13
FMT82025-01-17
LBI62018-05-01
MSX42024-07-12
CCK32023-04-05
FPL32014-09-10
MQM22014-11-13
FTD22013-03-08
DQA22008-11-26
DSA12025-09-30
CAH12022-12-07
DXN12011-02-18
DXG12008-01-03
DRQ12005-04-29
KOI12004-09-01
NHP12004-04-14
CCL11999-11-03
OLT11999-06-24
BTI11998-10-29
KLK11998-08-12
FLL11981-03-31

PMN#

BiliLux

2018-05-01

Draeger Medical Systems, Inc.

NBP CUFF

2009-11-24

DRAEGER MEDICAL AG & CO. KG

EVITE XL

2008-12-29

DRAEGER MEDICAL AG & CO. KG

148 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next